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Darunavir/Cobicistat (FDC)
Darunavir is a protease inhibitor that blocks HIV protease to prevent viral replication, while cobicistat is a boosting agent that inhibits CYP3A4 to increase darunavir levels.
Darunavir is a protease inhibitor that blocks HIV protease to prevent viral replication, while cobicistat is a boosting agent that inhibits CYP3A4 to increase darunavir levels. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection in combination with other antiretroviral agents.
At a glance
| Generic name | Darunavir/Cobicistat (FDC) |
|---|---|
| Sponsor | Janssen Scientific Affairs, LLC |
| Drug class | HIV protease inhibitor with pharmacokinetic booster |
| Target | HIV protease; CYP3A4 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Darunavir binds to and inhibits HIV protease, preventing the cleavage of viral polyproteins necessary for infectious particle maturation. Cobicistat acts as a pharmacokinetic booster by inhibiting cytochrome P450 3A4, significantly increasing darunavir plasma concentrations and allowing for lower, more convenient dosing. Together, they provide enhanced antiretroviral activity against HIV-1.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced adults
- HIV-1 infection in combination with other antiretroviral agents
Common side effects
- Diarrhea
- Nausea
- Headache
- Rash
- Abdominal pain
- Elevated liver enzymes
Key clinical trials
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults. (PHASE4)
- A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain (PHASE4)
- A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants (PHASE4)
- A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care (PHASE3)
- A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants (PHASE1)
- A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions (PHASE1)
- A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Darunavir/Cobicistat (FDC) CI brief — competitive landscape report
- Darunavir/Cobicistat (FDC) updates RSS · CI watch RSS
- Janssen Scientific Affairs, LLC portfolio CI